Back to resultsP.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems
Primary Purpose
Osteoarthritis, Knee
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
PFC Sigma Fixed Bearing
PFC Sigma Mobile Bearing
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria: Administrative - The patient or their authorised representative is able to understand the evaluation, is able to give voluntary written informed consent and will comply with the post operative follow up regime. Age - There are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation. Sex - Male or female (providing that they are not pregnant) may be recruited to the evaluation. Diagnosis - patients that require a tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis. Suitability - Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing tibial knee system and are suitable for patella resurfacing. Exclusion Criteria: Patients with rheumatoid arthritis. Patients requiring revision total knee arthroplasty surgery. Patients with any tibial deformity requiring tibial component augmentation. Patients that in the opinion of the clinical investigators require a constrained prosthesis. Patients with a known history of poor compliance to medical treatment. Patients who are known drug or alcohol abusers. Patients with a pathology which in the opinion of the clinical investigator will adversely affect healing. Patients who are currently participating in another clinical evaluation. Patients with other disorders which in the opinion of the Clinical Investigator will / could impair rehabilitation. Contra-indications for use of the device, as detailed in the package insert.
Sites / Locations
- Middlesborough General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
PFC Sigma Fixed Bearing
PFC Sigma Mobile Bearing
Arm Description
PFC Sigma Fixed Bearing system for use in total knee arthroplasty
PFC Sigma Mobile Bearing system for use in total knee arthroplasty
Outcomes
Primary Outcome Measures
To Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components
Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.
Secondary Outcome Measures
Change in SF-12 Physical and Mental Component Scores from Baseline to 1 and 2 years
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality. The response metric is the change score, or delta, from pre-operative assessment to post-operative assessment.
Change in American Knee Society Knee and Function Scores from Baseline to 1 and 2 years
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of Walking and Stair Climbing ability.
Change in Oxford Knee Score from Baseline to 1 and 2 years
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Change in Anterior Knee Pain from Baseline to 1 and 2 years
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe.
Incidence of Femoral Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Incidence of Tibial Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Incidence of Patellar Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00208286
Brief Title
P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems
Official Title
Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma Rotating Platform (Mobile Bearing) Total Knee Systems.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Primary study outcome achieved; investigator decided to conduct the study without sponsor support after 2009.
Study Start Date
November 2001 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. There were 120 knees consented by a single site, which was the planned sample size in the study protocol, with 117 receiving one of the study devices. The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009.
Detailed Description
Performance and safety will be assessed using the following surgeon and patient based outcome tools:
American Knee Society Knee and Function Scores
Knee Society Radiological Analysis
Oxford Knee Score
SF 12 Score
Anterior Knee Pain Score
Specific objectives of the evaluation being to assess the following:
Improvement in functional recovery
Incidence of anterior knee pain
Improvement in Quality of life
Incidence of tibial loosening
Incidence of excessive polyethylene wear
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PFC Sigma Fixed Bearing
Arm Type
Other
Arm Description
PFC Sigma Fixed Bearing system for use in total knee arthroplasty
Arm Title
PFC Sigma Mobile Bearing
Arm Type
Active Comparator
Arm Description
PFC Sigma Mobile Bearing system for use in total knee arthroplasty
Intervention Type
Device
Intervention Name(s)
PFC Sigma Fixed Bearing
Intervention Description
PFC Sigma Fixed Bearing system for use in total knee arthroplasty
Intervention Type
Device
Intervention Name(s)
PFC Sigma Mobile Bearing
Intervention Description
PFC Sigma Mobile Bearing system for use in total knee arthroplasty
Primary Outcome Measure Information:
Title
To Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components
Description
Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in SF-12 Physical and Mental Component Scores from Baseline to 1 and 2 years
Description
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality. The response metric is the change score, or delta, from pre-operative assessment to post-operative assessment.
Time Frame
1 and 2 years
Title
Change in American Knee Society Knee and Function Scores from Baseline to 1 and 2 years
Description
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of Walking and Stair Climbing ability.
Time Frame
1 and 2 years
Title
Change in Oxford Knee Score from Baseline to 1 and 2 years
Description
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time Frame
1 and 2 years
Title
Change in Anterior Knee Pain from Baseline to 1 and 2 years
Description
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe.
Time Frame
1 and 2 years
Title
Incidence of Femoral Radiolucencies at one year
Description
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Time Frame
6 weeks to 3 Months through 1 year
Title
Incidence of Tibial Radiolucencies at one year
Description
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Time Frame
6 weeks to 3 Months through 1 year
Title
Incidence of Patellar Radiolucencies at one year
Description
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Time Frame
6 weeks to 3 Months through 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Administrative - The patient or their authorised representative is able to understand the evaluation, is able to give voluntary written informed consent and will comply with the post operative follow up regime.
Age - There are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
Sex - Male or female (providing that they are not pregnant) may be recruited to the evaluation.
Diagnosis - patients that require a tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
Suitability - Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing tibial knee system and are suitable for patella resurfacing.
Exclusion Criteria:
Patients with rheumatoid arthritis.
Patients requiring revision total knee arthroplasty surgery.
Patients with any tibial deformity requiring tibial component augmentation.
Patients that in the opinion of the clinical investigators require a constrained prosthesis.
Patients with a known history of poor compliance to medical treatment.
Patients who are known drug or alcohol abusers.
Patients with a pathology which in the opinion of the clinical investigator will adversely affect healing.
Patients who are currently participating in another clinical evaluation.
Patients with other disorders which in the opinion of the Clinical Investigator will / could impair rehabilitation.
Contra-indications for use of the device, as detailed in the package insert.
Facility Information:
Facility Name
Middlesborough General Hospital
City
Middlesborough
Country
United Kingdom
12. IPD Sharing Statement
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P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems
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